Impact of Virtual Reality Hypnosis on Pain and Anxiety During Dressings Change in Burn Patients

Not Applicable

Withdrawn

• Conditions: Pain, Acute; Anxiety; Burns
• Interventions: Behavioral: VRH; Behavioral: VR

• Registration Number: NCT03924908
• Lead Sponsor: University of Liege

Brief Summary

Different non-pharmacological techniques, including hypnosis and virtual reality are currently used as complementary tools in the treatment of pain related to burn injury. A new technique called 'virtual reality hypnosis' (VRH) (Patterson et al., 2004), which encompasses a combination of both tools, is regularly used although its actual function remains unknown to this date. With the goal to improve our understanding of VRH combination effects, it is necessary to elaborate randomized and controlled research studies in order to understand their actual function in individual's perception. 100 patients who are treated as outpatients for burn care will be randomly assigned to virtual reality or VRH. Patients will receive one session of one of these techniques during burn dressing change.Physiological parameters will be recorded during dressing change. Participants will fill in a questionnaire evaluating their tendency to be absorbed and dissociated, and another evaluating their level of perceived immersion. Their level of anxiety, pain, fatigue and relaxation will be evaluated before and after the session. A short interview will also be conducted to give participants the opportunity to openly describe their experience.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-23
• Study Start: 2023-01-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-25
• Last Update Posted: 2023-06-27
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Burn patient treated as outpatient
• Burn surface area > or = 5% of the total body surface area
• mainly 2nd degree burn

Exclusion Criteria

• Psychiatric antecedents
• Claustrophobia
• Heavy hearing
• Visual impairment
• Face burn
• Conjunctivitis
• Consent not obtained

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
VRH	VRH	Virtual reality hypnosis
VR	VR	Virtual reality

Primary Outcome Measures

Name	Time	Method
Change in fatigue	5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")	Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No fatigue = 0, maximum fatigue = 10.
Change in anxiety: Visual Analogical Scale (VAS)	5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")	Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No anxiety = 0, maximum anxiety = 10.
Change in pain perception: Visual Analogical Scale (VAS)	5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")	Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No pain = 0, maximum pain = 10.
Change in relaxation level	5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")	Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No relaxation = 0, maximum relaxation = 10.

Secondary Outcome Measures

Name	Time	Method
Level of absorption at the moment	5 minutes after dressing change ("time 1")	Absorption will be measured as the two components of hypnosis. We will measure absorption and dissociation using the Visual Analogical Scales (VAS). VAS is from 0 to 10. 0 is not absorbed and 10 is really absorbed. When responding to a VAS item, participants will be asked to specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
Time perception	5 minutes after dressing change ("time 1")	We will ask to the patient his perception of time during the session.
Change in heart rate	5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")	Physiological parameter measured using pulse oximeter
Level of dissociation at the moment	5 minutes after dressing change ("time 1")	Dissociation will be measured as the two components of hypnosis. We will measure absorption and dissociation using the Visual Analogical Scales (VAS). When responding to a VAS item, participants will be asked to specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.